• Komal Rajendra Malik
• Dr. Vipul P. Patel
• Vikas Shantaram Ahirrao
• Sonali Rajendra Malik

Recently, the use of biorelevant testing conditions has become standard in the characterization of new compounds and development of formulations. They can also be used as the basis for developing appropriate quality control test, under consideration of appropriate pH, buffer capacity and osmolality. Therefore, the approach described in the present paper might be very helpful for developing predictive and discriminatory methods in early formulation development for poorly soluble drugs and which could also be adopted for QC. In vitro biorelevant dissolution tests enabling the prediction of in vivo performance of an oral dosage form. The present paper involves information about dissolution media simulating fasted and fed states especially for poorly soluble drugs, effect of food on drug release and case example of biorelevant dissolution tests for prediction of in vivo performance of diclofenac sodium from an oral modified release pellet dosage form.

Dissolution; biorelevant dissolution media; fasted and fed state; poorly soluble drugs; discriminatory test.

"Biorelevant and Discriminatory Dissolution Tests for Design and Development of Dosage Form: A Scientific Review", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.7, Issue 7, page no.2163-2171, July-2020, Available :http://www.jetir.org/papers/JETIR2007277.pdf

"Biorelevant and Discriminatory Dissolution Tests for Design and Development of Dosage Form: A Scientific Review", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.7, Issue 7, page no. pp2163-2171, July-2020, Available at : http://www.jetir.org/papers/JETIR2007277.pdf